F U N G ITELL ® A S SAY

S E RU M TEST FOR
(1 g 3) - b - D - GLUCAN

An FDA-Cleared, 510(k) in vitro diagnostic

The Gold Standard in Rapid Screening For Invasive Fungal Infection (IFI)

Fungitell® is the first and the only FDA-cleared and CE marked rapid in vitro diagnostic screening test
for IFI (including Candida, Aspergillus and Pneumocystis) that detects (1g3)-b-D-Glucan in serum.
 FUNGITELL ®
THE GOLD STANDARD IN RAPID SCREENING
Invasive fungal infection: More aggressive medical care, including immunosuppressive therapy and ICU care

has greatly increased the population of patients at risk of invasive fungal infection (IFI). There are an estimated 40-60

thousand invasive fungal infections in the USA annually1. Candidemia represents the 4th leading cause of nosocomial

blood stream infection and the 3rd most common ICU bloodstream infection2.

The low sensitivity and relatively long incubation times of microbial culture, the most widely used diagnostic

technique, has resulted in a need for faster methods with greater sensitivity. With its high sensitivity and rapid

availability of results, the demand for Fungitell® has increased steadily since its clearance by the FDA in 2004.

Early diagnosis and treatment have been shown to have increased survival rates in Candidal Shock3

Delay in Therapy
Administration (Hr): Survival

0-2 ~ 82%

2-6 ~ 65%

6-12 ~ 17%

12-24 ~ 9%

24-72 ~ 8%

FU N GA L
TRE ND S &
STAT I S T I C S

1 www.fungitell.com
ASSAY
FOR INVASIVE FUNGAL INFECTION
At Risk Patients
Invasive Fungal Infection is increasing in at risk popula-
tions13 such as:

• Aggressive Care (SICU/MICU/NICU)

• Mechanical Ventilation

• Stem Cell and Organ Transplants

• HIV

• Cancer Treatment

• Diabetes

• Central Venous Catheters

• Hemodialysis

• Gastrointestinal Surgery

• Total Parenteral Nutrition

Why Test For (1g3)-b-D-Glucan Opportunities

Most pathogenic fungi* have (1g3)-b-D-Glucan in their Fungitell®, an FDA cleared and CE marked diagnostic
cell walls and minute, but detectable quantities are test, is used for the detection of (1g3)-b-D-Glucan,
released into the circulation during infection. Detection which is frequently associated with the presence of
of elevated levels of (1g3)-b-D-Glucan is an aid to the fungal pathogens. The majority of these are Candida
presumptive diagnosis of invasive fungal infection (IFI) in and Aspergillus species.
at risk patients.
There are, potentially, clinical applications that could
Multiple studies 4,5,6,7,8
have shown glucan to become benefit from utilizing the (1g3)-b-D-Glucan test where
elevated well in advance of conventional clinical signs pneumocystosis is suspected.
and symptoms. The early diagnosis of and administration
The Fungitell® Assay
of therapy for invasive fungal infection is associated
Features and Benefits
with improved clinical outcome; delayed diagnosis
and therapy is associated with increased mortality9. - Provides earlier support for diagnosis of IFI
Conversely, the elevated morbidity and mortality
- Detects glucan from most fungi including 
associated with invasive fungal infection drives poten-
Candida and Aspergillus*
tially inappropriate systemic antifungal therapy. Research
- Rapid results within an hour
studies have demonstrated the utility of negative
Fungitell® results to support decisions to withhold or - FDA Cleared
withdraw antifungals with excellent patient safety. 10,11,12
- CE Marked
Hence, there is significant utility in the application of
the Fungitell® test in at risk patients.

www.fungitell.com 2
FU N GI TE L L ®
ASS AY
PRO DU C T
I NFO RM AT I O N
Principle of the Fungitell® Reagent
Fungitell® is a (1g3)-b-D-Glucan specific Limulus ame-
bocyte lysate (LAL) reagent containing a chromogenic
peptide substrate. (1g3)-b-D-Glucan in the sample
causes activation of serine proteases. An activated
protease cleaves p-nitroaniline (pNA) from the peptide
substrate and the free pNA is measured at 405 nm.
The test is run in a standard incubating plate reader.
Materials Supplied with the Kit
• 2 vials Fungitell Reagent
® patients, serum (1g3)-b-D-Glucan values of at least
• 2 vials Pyrosol® Reconstitution Buffera
• 2 vials Glucan Standard
• 2 bottles Reagent Grade Water, 20 mL
a
• 2 vials Alkaline Pretreatment Solution a
Storage Conditions
Store all reagents at 2-8°C in the dark. Reconstituted
Fungitell reagent should be stored at 2-8°C and used
®
within 2 hours. Alternatively, reconstituted Fungitell
reagent can be frozen at -20°C for 20 days, thawed
once and used.
Materials Required but not Supplied
All materials and glassware must be free of inter-
fering glucan. Dry heat depyrogenation is effective in
eliminating interfering levels of (1g3)-b-D-Glucan
from glass surfaces.
Purchase supplies from a supplier that will certify the
materials free of interfering glucan.
3 www.fungitell.com
• 96-well microplateb
• Repeating Pipette and tips (250 mL; 1000 mL)b
• Test tubes for sample dilution (13 x 100 mm)b
• Glass pipettes – not plastic
• Parafilm®
• Incubating plate reader capable of reading
at 405 and 490 nm with appropriate kinetic
software for determination of Vmeanb
• Vortex mixer
Order Information
FT001 Fungitell® Kit-110 test wells
The Fungitell® assay is a highly sensitive, micro-
plate-based test that detects (1g3)-b-D-Glucan in
serum. (1g3)-b-D-Glucan is a cell wall constituent of
most medically important fungi including Candida and
Aspergillus.* (1g3)-b-D-Glucan is normally found at
low levels in the blood of healthy humans. In at risk
80 pg/mL, are highly associated with invasive fungal
infection. Conversely, low levels of (1g3)-b-D-Glucan
have a high negative predictive value for invasive
fungal infection.
(1g3)-b-D-Glucan detection is not subject to the
usual interferences. It is not suppressed by anti-fungal
therapy, nor is the test cross-reactive with other
polysaccharides.
®
Diagnostic Performance
Multiple studies4,5,6,7,8 in diverse patient groups
have shown sensitivities from 70–100% and high
negative predictive values. A variety of studies also
demonstrate diagnostic utility in Pneumocystis jirovecii
pneumonia14,15.
Rapid Results
The Fungitell® assay is performed entirely within a
microplate well without washing steps. The assay
provides results within an hour.
Antimicrobial Stewardship
Studies have shown that early discontinuation of
empirical therapy in high-risk ICU patients based on
consecutive negative BDG tests may be a reasonable
strategy, with great potential to reduce the overuse of
antifungals13.
Marketplace Longevity
Fungitell® has over a decade of proven clinical use
and has been referenced in over 125 peer-reviewed
clinical papers.
Warnings, Precautions and Limitations
(see instructions for use for details):
i. The tissue locations of fungal infection and en-
capsulation may affect the serum concentration
of (1g3)-b-D-Glucan.
ii. Some individuals have elevated levels of (1g3)-b-
D-Glucan that fall into the indeterminate zone
of 60 – 79 pg/mL. In such cases, additional testing
is recommended.
iii. Test levels were established in adult subjects.
Infant and pediatric normal levels approach those
of adults. Data for neonates, and infants less than
six months, are lacking.
iv. Off-color or turbid samples such as those that are
grossly hemolyzed, lipemic, or contain excessive
bilirubin may cause interference.
v. Samples obtained by heel or finger stick methods
are unacceptable as the alcohol-soaked gauze
used to prepare the site and/or skin surface-pool-
ing of blood may contaminate the specimens.
vi. Surgical gauzes and sponges can leach high levels
of (1g3)-b-D-Glucan and may contribute to a
transient positive result for the Fungitell® assay.
vii. The serum of hemodialysis patients may contain
high levels of (1g3)-b-D-Glucan when certain
cellulose dialysis membranes are used.
www.fungitell.com
viii. In performing the test, great care must be taken
to avoid contamination.
ix. The use of Fungitell® for purposes other than those
described in the Intended Use section of instruc-
tions for use of the product is neither recommend-
ed nor supported by Associates of Cape Cod, Inc.
References:
1. Pfaller, M.A., (2009) Focus on Fungal Infection 19 Proceedings.
2. Reboli, A.C., (2009) Focus on Fungal Infection 19 Proceedings.
3. Kumar, A et al. Poster 2174 ICAAC 2007
4. Odabasi Z., Mattiuzzi G., Estey E., Kantarjian H., Saeki F., Ridge R., Ketchum P., Finkelman
M., Rex J. and Ostrosky-Zeichner L. (2004) Beta-D-Glucan as a diagnostic adjunct for
invasive fungal infections: Validation, cutoff development, and performance in patients
with Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Clinical Infectious
Diseases. 39:199-205.
5. Ostrosky-Zeichner L., Alexander B., Kett D., Vazquez J., Pappas P., Saeki F., Ketchum P.,
Wingard J., Schiff R., Tamura H., Finkelman M., and Rex J. (2005) Multicenter clinical
evaluation of the (1g3)-b-D-Glucan assay as as aid to diagnosis of fungal infections in
humans. Clin. Inf. Dis. 41: 654-659.
6. Pazos C., Ponton J., and Del Palacio A. (2005) Contribution of (1g3)-b-D-Glucan chromo-
genic assay to diagnosis and therapeutic monitoring of invasive aspergillosis in neutropenic
adult patients: A comparison with serial screening for circulating galactomannan. J. Clin.
Micro. 43(1): 299-305.
7. Pazos, C., Moragues, M-D., Quindos, G., and del Palacio, A. (2006) Diagnostic potential of
(1g3)-b-D-Glucan and anti-Candida albicans germ tube antibodies for the diagnosis and
therapeutic monitoring of invasive candidiasis in neutropenic adult patients. Re. Iberoam
Micol. 23: 209-215.
8. Ellis, M., Ramadi, B., Finkelman, M., Hedstrom, U., Kristenson, J., Ali-Zadeh, H., and
Klingspor, L. (2007) Assessment of the clinical utility of serial b-D-Glucan concentrations in
patients with persistent neutropenic fever. J. Med. Microbiol. 57: 287-95.
9. Morrell, M., Fraser, V., and Kollef, M. (2005) Delaying the empiric treatment of Candida
bloodstream infection until positive culture results are obtained: a potential risk factor for
hospital mortality. Antimicrob. Agents. Chemother. 49: 3640-3645.
10. Prattes, J., Hoenigl, M., Rabensteiner, J., Raggam, R.B., Prueller, F., Zollner-Schwetz,
I., Valentin, T., Hönigl, K., Fruhwald, S., and Krause, R. , Serum 1,3–beta-D-glucan for
the antifungal treatment stratification at the intensive care unit and the influence of
surgery, Mycoses Diagnosis, Therapy and Prophylaxis of Fungal Diseases, June 2014
11. Nucci, M., Nouér, S.A., Esteves, P., Guimarães, T., Breda, G., Grassi de Miranda, B.,
Queiroz-Telles, F., and Colombo, A.L., Discontinuation of empirical antifungal therapy
in ICU patients using 1,3-b-D-glucan, Journal of Antimicrobial Chemotherapy Advance
Access. published June 10, 2016.
12. Posteraro, B., Tumbarello, M., De Pascale, G., Liberto, E., Vallecoccia, M.S., De Carolis,
E., Di Gravio, V., Trecarichi, E.M., Sanguinetti, M. and Antonelli, M., (1,3)-b-D-Glu-
can-based antifungal treatment in critically ill adults at high risk of candidaemia: an
observational study, Journal of Antimicrobial Chemotherapy Advance Access published
April 28, 2016
13. Enoch et al., (2006) JMM 55:809-818.
14. Marty, F. M., Koo, S., Bryar,and J., Baden, L.R. (2007) (1g3)-b-D-Glucan assay
positivity in patients with Pneumocystis (carinii) jirovecii pneumonia. Ann. Int. Med.
147: 70-72.
15. Persat F, Ranque S, Derouin F, Michel-Nguyen A, Picot S, Sulahian A (2008) Contribu-
tion of the (1g3)-b-D-Glucan Assay for the Diagnosis of Invasive Fungal Infections. J.
Clin. Micro. 36: 1009-1013.
a. Products are free of interfering glucans
b. Available from Associates of Cape Cod, Inc.
*Cryptocuccus, Zygomycetes (such as Absidia, Mucor and Rhizopus) and Blastomyces
dermatitidis (infective yeast form) are known to have little or no (1g3)-b-D-Glucan and thus,
glucan is not detected during infection with these organisms.
4
FU N GI TE L L ® A S S AY
TE S T P R O C E D U R E OU TLIN E

SET-UP
SET-UP

1 Reconstitute glucan stock

and make standards.
2 Pipette 5 µL of sample 5µL
into Pyroplate wells.

TESTSAMPLES
TEST SAMPLES

3 4 5 6
Add 20 µL Incubate Reconstitute Add 25 µL
of alkaline at 37º C for Fungitell® standards
pretreatment 10 minutes. Reagent. to Pyroplate.
solution into
Pyroplate sample
wells.
20µL 25µL

7 8 9 Read report data.

Add 100 µL of Incubate and collect
Fungitell® lysate kinetic data at 37º C Fung
itell ®
Assay
100µL
reagent into for 40 minutes. Patien
Report
Date:

Pyroplate wells. I.D.

t Beta-G
lucan
pg/m Interp
L retati
on
~~~
~~
35
~~~
~~ -
70
~~~ n/a
~~
290
+

NOTE: For complete test procedure refer to Fungitell® Instructions For Use (IFU).
5 www.fungitell.com
About Beacon
The Beacon Diagnostics® Laboratory is a fully CLIA-certified
reference laboratory specializing in (1g3)-b-D-Glucan analysis
services to support the diagnosis of Invasive Fungal Infection Specimen Requirements
(IFI). Serving clinical and reference laboratories, we offer a Each sample sent to Beacon Diagnostics® Laboratory for testing
rapid, cost-effective alternative to in-house testing. must be accompanied by a completed Sample Submission Form.
Forms can be obtained by calling (800) 568–0058 or by visiting
The laboratory is a division of Associates of Cape Cod, Inc. The
our website at www.BeaconDiagnostics.com.
expert staff at Beacon Diagnostics® Laboratory provides clients
with rapid diagnostic and analytical service, to assist in the • Please provide at least 0.5 mL of serum separated from the clot
medical evaluation of patients suspected of having invasive and shipped cold or frozen on ice packs or dry ice. Secure the
fungal infection. Our laboratory also tests veterinary samples. vial closure with Parafilm® or tape. Next day shipping is required.
We currently hold certifications and licenses in Massachusetts,
• Serum should be shipped in a sterile, clean, screw-cap plastic
California, Florida, Maryland, New York, Pennsylvania and
vial (most cryogenic vials certified DNAse and RNAse free are
Rhode Island. An updated list can be found on our website at
typically suitable for use). Do not send serum in glass tubes.
www.BeaconDiagnostics.com.
Samples not separated from the clot prior to shipment may
Additional information concerning the applications and latest incur an additional handling and preparation fee.
findings of (1g3)-b-D-Glucan testing in patients can also be
• Avoid contact between the serum and potential sources of
found on our website.
(1g3)-b-D-Glucan contamination including cellulosic filters,
Hours of Operation gauze, and cotton swabs.
Testing: Mon.-Fri., 8:00 a.m. to 6:00 p.m. EST
• Hemolyzed, lipemic, and icteric samples are not suitable for
Sample Receiving: Mon.-Sat., 8:00 a.m. to 7:00 p.m. EST
testing.
CLIA License Number: 22D1021258

• Samples must be shipped in accordance with federal shipping

Test Information and Sample Requirements
requirements for Clinical Diagnostic Specimens.
Pricing and Current Procedure Terminology (CPT) Coding

• Call for Pricing • Use Red Top Tubes

• The Fungitell® assay does not have an assigned CPT code.
Commonly accepted laboratory practice for coding a diag-
nostic test is to seek an existing CPT code that exactly de-
scribes the test; i.e. the organism, methodology, analyte and
sample, as appropriate. If there is no exact match, then a code
is chosen that most closely describes the laboratory procedure
on the basis of methodology. Based on comparison of the
test characteristics to the CPT code description, commonly ac-
cepted coding practice may allow coding for Fungitell® using
87449. The coding preferred by individual payers may vary.
Please check with your payer for specific billing instructions.
• Heel and finger stick samples are inappropriate
• Our laboratory also tests veterinary samples.
Note: To maintain optimal sample temperatures during transit,
especially during the warm summer months, it is advisable to
use insulated shipping containers (e.g. Styrofoam liners) and
extra cold packs or dry ice when shipping samples.
Contact Information
Beacon Diagnostics® Laboratory
124 Bernard E. Saint Jean Dr., E. Falmouth, MA 02536

Technical information and sample submission:

Testing and Turn-around Time
Tel: (800) 568–0058 • Fax: (508) 444–1481
Testing is performed Monday through Friday. Typical turnaround
E-mail: info@beacondiagnostics.com
time is about 48 hours from receipt of sample at our facility,
but most results are available the same day they are received.
www.fungitell.com 6
Corporate Headquarters
Associates of Cape Cod, Inc.
124 Bernard E. Saint Jean Drive
East Falmouth, MA 02536-4445 USA
Tel: (888) 395–ACC1(2221) or
(508) 540–3444
Fax: (508) 540–8680
www.acciusa.com
Customer Service:
custservice@acciusa.com
Technical Service:
techservice@acciusa.com
Contract Test Service:
testservice@acciusa.com

United Kingdom
Associates of Cape Cod Int’l., Inc.
Deacon Park, Moorgate Road
Knowsley, Liverpool L33 7RX
United Kingdom
Tel: (44) 151–547–7444
Fax: (44) 151–547–7400
E-mail: info@acciuk.co.uk
www.acciuk.co.uk
Company Registration Number:
BR002906

Germany
Associates of Cape Cod Europe GmbH
Opelstrasse 14
D-64546 Mörfelden-Walldorf
Germany
Tel: (49) 61 05–96 10 0
Fax: (49) 61 05–96 10 15
E-mail: service@acciusa.de
www.acciusa.de

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All Rights Reserved. PR18-016